MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Kinked (1339); Aspiration Issue (2883); Device Operates Differently Than Expected (2913)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8781, serial (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2018, product type: catheter. If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative on 2018-feb-20 regarding a patient receiving fentanyl (1291 mcg/ml at 199 mcg/day), bupivacaine (20 mg/ml at 3 mg/day), and dilaudid (0. 9 mg/ml at 0. 139 mg/day) via an implanted infusion pump. The indication for use was non-malignant pain. Other medications the patient was taking at the time of the event included amoxicillin, baclofen, cymbalta, pepcid, neurontin, synthroid, ativan, magog, imodium, prevalite, mycostatin, oxycodone, desyrel, bactrim, and claritin. The patient's medical history included paraplegic status, diabetes mellitus (dm), osteoporosis, decubitus ulcer, colostomy, "hz dvts," pyelonephritis, septic shock, urinary tract infections (utis) with sepsis, hypothyroidism, urostomy, metabolic encephalopathy, and acute renal failure. It was reported that the patient was having increased pain on an unknown date. A catheter dye study was done on (b)(6) 2018, but failed as the hcp was unable to aspirate the catheter. Surgery occurred on (b)(6) 2018 and the catheter was found to be kinked near the anchor. The catheter was cut above the kink and the hcp was able to aspirate cerebrospinal fluid (csf). The flow was sluggish, so the spinal segment was replaced. The issue was considered resolved and the patient's status at the time of report was alive - no injury. No further complications were reported or anticipated.

Manufacturer Narrative

Refers to the main device, the other relevant component includes: product id 8781 (b)(4) implanted: (b)(6)2015 explanted: (b)(6)2018; product type catheter; ubd: (b)(4)2017; (b)(6). Of note, only the catheter was returned for analysis. Evaluation of implantable catheter (b)(4) revealed no significant anomalies. However, only a small segment of the catheter was returned for analysis. Analysis identified melting damage on the catheter consistent with explant damage. Device code (b)(4) has been added. The evaluation codes have also been updated. If information is provided in the future, a supplemental report will be issued.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7287003
• MDR Text Key: 100611080
• Report Number: 3004209178-2018-03726
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 02/21/2018 Patient Sequence Number: 1